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Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word(STONE)

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ClinicalTrials.gov Identifier: NCT03054818
Recruitment Status : Unknown
Verified February 2017 by Chengdu Kanghong Biotech Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co., Ltd.

Brief Summary:
This is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner. Safety information about patients who have received intravitreal injection of Conbercept Ophthalmic Injection in medical institutions involved in the study during research will be actively monitored without intervening in diagnosis and treatment. All patients enrolled will be followed up for one year.

Condition or disease
Wet Age-related Macular Degeneration (wAMD)

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word
Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. New Adverse Reactions [ Time Frame: 1 year ]
    To observe the type, incidence and severity of new adverse reactions in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study;

  2. Common Ocular Adverse Events [ Time Frame: 1 year ]
    To observe the type, incidence and severity of common ocular adverse events in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study, including: 1) bleeding at injection site; 2) increased intraocular pressure (IOP); 3) conjunctival congestion; 4) conjunctivitis; 5) decreased visual sensitivity; and 6) muscae volitantes.

  3. Common Ocular Adverse Events [ Time Frame: 1 year ]
    To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.


Secondary Outcome Measures :
  1. Other Ocular Adverse Events [ Time Frame: 1 year ]
    To observe the type, incidence and severity of other ocular adverse events in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study.

  2. Other Ocular Adverse Events [ Time Frame: 1 year ]
    To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

  3. Non-ocular Adverse Events [ Time Frame: 1 year ]
    To observe the type, incidence and severity of non-ocular adverse events during the study

  4. Non-ocular Adverse Events [ Time Frame: 1 year ]
    To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

  5. Adverse Events of Special Interest(AESI) [ Time Frame: 1 year ]
    To observe the incidence and severity of adverse events of special interest (AESI) during the study, including: 1) retinal detachment; 2) retinal tears; 3) retinal pigment epithelial detachment; 4) retinal pigment epithelium tears; 5) geographic atrophy; 6) endophthalmitis; 7) arterial thromboembolic events (ATEs); and 8) hypertension

  6. Adverse Events of Special Interest(AESI) [ Time Frame: 1 year ]
    To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.

  7. SAE [ Time Frame: 1 year ]
    To observe the type, incidence and severity of all severe adverse events during the study

  8. SAE [ Time Frame: 1 year ]
    To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.

  9. Adverse Events Related to Intravitreal Injection Practices [ Time Frame: 1 year ]
    To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.

  10. Adverse Events of Special Population [ Time Frame: 1 year ]
    To observe the incidence and severity of adverse events of special population during the study,including children and adolescents (aged under 18), and pregnant women.

  11. Adverse Events of Special Population [ Time Frame: 1 year ]
    To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All medical academies will initially identify whether patients are enrolled based on baseline registration information.
Criteria

Inclusion Criteria:

  1. The condition that informed consent has been freely given prior to research-related procedures;
  2. Patients who have received at least one intravitreal injection of Conbercept Ophthalmic Injection after informed consent has been given.

Exclusion Criteria:

  1. Patients who have been on any of other anti-VEGF drugs systematically or locally, including but not limited to bevacizumab, ranibizumab and aflibercept, 90 days before enrollment;
  2. Those who are on other study drugs or have been on other study drugs 30 before informed consent is given.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054818


Contacts
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Contact: Ningli Wang 010-58265922 wningli@vip.163.com

Locations
Show Show 49 study locations
Sponsors and Collaborators
Chengdu Kanghong Biotech Co., Ltd.
Investigators
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Principal Investigator: Ningli Wang BEIJING TONGREN HOSPITAL, CMU
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Responsible Party: Chengdu Kanghong Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03054818    
Other Study ID Numbers: RG01N-1578-1.0
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases